Events

Rappel de Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bio-Rad Laboratories Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00146-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00146-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Bio-rad have observed that intact pth may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts. there is a possibility that intact pth values in the lots affected may gradually shift down due to a decrease in stability when the product is stored at 2 to 8°c. the claims for intact pth have been revised from 23 days to 7 days.Although unlikely, the reported issue may result in a delay in result reporting or the false signalling of an in-control situation.
  • Action
    Bio-Rad is advising users not to use the control for intact PTH beyond 7 days when stored at 2 to 8°C. Users are able to obtain a revised package insert with the updated stability time frames from http://myeinsters.qcnet.com

Device

Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)Master Lot Numbers:57430, 57440, 57450, 57460, 57470, 57480, and 57490ARTG Number: 194959
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd